NCT01570179

Sugammadex-dosing in Bariatric Patients

Sugammadex in Patients Undergoing Bariatric Surgery: An Equivalence Trial Comparing Real and Ideal Body Weight-based Dosing

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Central Hospital, Nancy, France · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Should the dose of sugammadex in morbid obese patients be calculated on the real body weight or the ideal body weight? The main objective of the trial is to compare in patients undergoing bariatric surgery the efficacy of sugammadex to obtain a TOF-ratio of 100% within 3 min when dosing is based on real body weight (control intervention) with dosing based on ideal body weight (experimental intervention). The research hypothesis is that both dosing regimens are equivalent The secondary objective of the trial is to compare the impact of the depth of neuromuscular blockade on the surgical conditions: deep block (TOF-count 1 - 3) will be compared with very deep block (TOF count = 0 and PTC \< 5)

Conditions

• Neuromuscular Blockade

Interventions

Type	Name	Description
DRUG	ideal BW based sugammadex reversal of moderate block	2 mg/kg sugammadex (based og ideal body weight)
DRUG	real body weight based sugammadex reversal of moderate block	2 mg/kg sugammadex (based on real BW)
DRUG	real body weight based sugammadex reversal of deep block	4 mg/kg sugammadex (based on real BW)
DRUG	ideal body weight based sugammadex reversal of deep block	4 mg/kg sugammadex (based on ideal BW)

Timeline

• Start date: 2012-05-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2012-04-04
• Last updated: 2013-01-24

Locations

2 sites across 1 country: France